PMA P860003S030
- Device
- UVAR PHOTOPHORESIS SYSTEM
- Applicant
- Therakos Development Limited
- PMA number
- P860003
- Supplement
- S030
- Product code
- LNR
- Decision date
- 1999-09-07
- Classification
- System, Photopheresis, Extracorporeal
- Generic name
- System, photopheresis, extracorporeal
- Approval order statement
- Approval for a labeling change to reflect the use of UVADEX(R), the sterile liquid formulation of 8-methoxypsoralen (8-mop).
Current openFDA PMA Record#
- Device
- UVAR PHOTOPHORESIS SYSTEM
- Applicant
- Therakos Development Limited
- PMA number
- P860003
- Supplement
- S030
- Product code
- LNR
- Generic name
- System, photopheresis, extracorporeal
- Decision date
- 1999-09-07
- Decision code
- APPR
- Date received
- 1998-04-29
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a labeling change to reflect the use of UVADEX(R), the sterile liquid formulation of 8-methoxypsoralen (8-mop).